Generics/General

Generic drug growth in Brazil and Venezuela

Generics/General | Posted 15/09/2023

Over the past few years, both Brazil and Venezuela have witnessed an increase in the production, growth, and acceptance of generic medicines in their respective healthcare systems.

Market penetration of generic drugs in Mexico and Brazil

Generics/General | Posted 27/04/2023

Generic drugs represent a great advance both in Brazil and Mexico, as they allow the population to access affordable, safe and effective treatments.

FDA releases one-year progress report for the Generic Drug Cluster

Generics/General | Posted 28/10/2022

The US Food and Drug Administration’s (FDA) one-year progress report for the Generic Drug Cluster – a multi-country forum on generic drugs – explains the purpose of the Cluster and key achievements made so far.

Pharmaceutical manufacturing companies in Brazil

Generics/General | Posted 26/08/2022

Brazil is a country active in life sciences research, publications, manufacturing and exports. Biosimilars have the highest growth potential for the pharmaceutical sector in Latin America [1].

Pharmaceutical companies in Argentina

Generics/General | Posted 08/07/2022

Argentina has an important pharmaceutical sector, being the third largest market in Latin America after Brazil and Mexico. Pharmaceutical companies from Denmark, France, Germany, Switzerland, the UK and the US are stablished in Argentina. Argentine market has extensive experience in the incorporation of foreign investments for the sector as well as offers multiple business opportunities.

Pharmaceutical companies in Latin America and the Caribbean

Generics/General | Posted 24/06/2022

According to a research carried out by Vargas V, et al. 2022, pharmaceutical innovations, together with higher living standards and more effective public health interventions, have been significantly important to extend life expectancy and improve population quality of life in Latin America and the Caribbean [1].

Canada calls for support to national pharmacare and generics industry

Generics/General | Posted 10/06/2022

Canada has made a federal budget commitment to supporting a national pharmacare programme. This can be bolstered through strengthening Canada’s domestic generics pharmaceutical industry.

UK NHS faces drug shortages

Generics/General | Posted 27/05/2022

The United Kingdom’s (UK) National Health Service (NHS) faces shortages of blood pressure pills, painkillers and antidepressants due to drug manufacturer supply problems.

High drug bills? Turn to your pharmacist for help

Generics/General | Posted 15/04/2022

Many Americans require prescription drugs on a daily basis. With year-on-year price increases of branded products, turning to pharmacists for advice could reduce the financial strain on households [1, 2].

FDA Office of Generic Drugs publishes 2021 annual report

Generics/General | Posted 01/04/2022

The US Food and Drug Administration’s (FDA) Office of Generic Drugs annual report reveals the importance of innovation and scientific collaboration in advancing the generic drug programme in 2021.

COVID-19 vaccine produced in Latin America

Generics/General | Posted 18/03/2022

The World Health Organization (WHO) approved a COVID-19 vaccine produced in Latin America at the end of 2021. It is a version of the immunizing agent from the Anglo-Swedish laboratory AstraZeneca, manufactured jointly by Argentina and Mexico.

Drug shortages hit Japan and Europe

Generics/General | Posted 04/02/2022

Shutdowns of pharmaceutical companies have led to shortages of generic drugs in Japan, while in the EU, existing shortages have been exacerbated by the COVID-19 crisis.

Generics applications under review by EMA – January 2022

Generics/General | Posted 28/01/2022

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

Medicines repurposing project launched in Europe

Generics/General | Posted 21/01/2022

In late October 2021, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced the launch of a pilot project to support the repurposing of medicines.

MPP agreements allow generics production of Merck and Pfizer’s COVID-19 treatments

Generics/General | Posted 10/12/2021

In October and November 2021, Merck and Pfizer signed licensing agreements with the United Nation’s backed Medicines Patent Pool (MPP) to help increase access to their investigational COVID-19 oral antiviral treatment options. Respectively, these are molnupiravir and Paxlovid. Creating these royalty free licences will allow for generic versions of the drugs to be produced and distributed in approximately 100 low- and middle-income countries worldwide.

FDA closes Zhejiang Huahai Pharmaceutical warning letter

Generics/General | Posted 19/11/2021

The US Food and Drug Administration (FDA) has stated that it has closed the warning letter issued to Chinese manufacturer Zhejiang Huahai Pharmaceutical in 2018.

FDA reaches 100 generics approvals

Generics/General | Posted 12/11/2021

As of September 2021, the US Food and Drug Administration (FDA) has reached an important milestone of approving more than 100 generic drug applications with a competitive generic therapy (CGT) designation.

New five-year medicines agreements in Australia

Generics/General | Posted 24/09/2021

The Australian Government has entered into five-year strategic agreements with Medicines Australia and the Generics and Biosimilar Medicines Association (GBMA), to improve access to affordable, innovative, and life-saving therapies, vaccines and medicines.

Generics applications under review by EMA – July 2021

Generics/General | Posted 23/07/2021

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

A European pharmaceutical strategy promoting generics and biosimilars

Generics/General | Posted 08/01/2021

The European Commission has adopted a new Pharmaceutical Strategy for Europe [1], as of 25 November 2020.